Development and Testing of a Multi-use Frameworks Playbook for Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) (U01 Clinical Trial Not Allowed)

The Development and Testing of a Multi use Frameworks Playbook for Precision Medicine with AI Integrating Imaging with Multimodal Data program is a federal funding opportunity administered by the National Institutes of Health through the Office of Strategic Coordination under the NIH Common Fund. The initiative is part of a broader PRIMED AI program designed to accelerate biomedical discovery and improve clinical care by integrating imaging data with other multimodal health data sources. This opportunity focuses specifically on supporting the development of standardized frameworks that guide the creation, validation, and deployment of artificial intelligence based clinical decision support tools. The primary objective of this funding opportunity is to solicit applications for the design, development, and preliminary validation of robust frameworks that can be compiled into a playbook. These frameworks are expected to consist of actionable guidelines, standardized protocols, and standard operating procedures that enable the reliable and effective development of multimodal AI tools. The playbook is intended to serve as a shared resource that can be adopted broadly across the biomedical research community, supporting both internal PRIMED AI program needs and external applications. The initiative emphasizes flexibility, interoperability, and scalability to ensure that resulting frameworks can be applied across diverse clinical and research environments. Funding under this opportunity is provided through cooperative agreements, reflecting substantial involvement from NIH program staff in guiding and coordinating project activities. The program anticipates approximately five awards with total funding of about 2000000 dollars for fiscal year 2027. Individual projects may request up to 300000 dollars in direct costs per year, with a maximum project period of two years. Projects are expected to be discrete and focused on the development of at least two distinct frameworks addressing different aspects of multimodal AI development, such as data quality, model transparency, interoperability, or regulatory navigation. Eligibility for this opportunity is broad and includes public and private higher education institutions, nonprofit organizations, for profit entities including small businesses, and various levels of government including state, local, and tribal entities. However, foreign organizations and non domestic components of US organizations are not eligible. Applicants must ensure all required registrations are completed prior to submission, including SAM, Grants.gov, and eRA Commons, and must comply with NIH application guidelines and policies. Cost sharing is not required for this program. The application process requires submission through Grants.gov using NIH approved systems such as ASSIST or institutional system to system solutions. Applicants must adhere strictly to the NIH Application Guide and include detailed research strategies outlining framework development plans, team composition, data types, and intended use cases. Applications must also include plans for collaboration within the PRIMED AI consortium, milestone tracking, performance reporting, and data sharing. Noncompliant applications may be rejected without review. Applications are evaluated through the NIH peer review process based on criteria including significance and innovation, rigor and feasibility, and investigator expertise and environment. Additional considerations include the potential impact of proposed frameworks on advancing multimodal AI and their adaptability across clinical settings. Projects must demonstrate clear plans for collaboration, usability, and dissemination of frameworks to ensure broad adoption. The timeline for this opportunity includes a posted date of June 30 2026 and a submission deadline of October 9 2026. Applications must be submitted by 5:00 PM local time of the applicant organization. Review is expected in March 2027, with advisory council review in May 2027 and earliest project start date in July 2027. The opportunity expires on October 10 2026 and does not accept late submissions.

Ensure frameworks are distinct and not duplicative emphasize interoperability and real world clinical applicability demonstrate collaboration readiness and clear milestones